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Terminated

Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.

FDA Recall Z-1332-04 · Posted 2004-08-10

Recalling FirmAdvanced Bionics Corporation
Recall StatusTerminated
Product CodeMCM
Date Initiated2004-07-27
Date Terminated2012-03-23
Product Quantity2458

Reason for Recall

Battery pack may overheat and cause patient burns.

Firm Action

Notification letters were sent to all users and affiliates on July 27, 2004. Initially customers were informed that they will receive a retrofit kit. Firm decided to actually recall the battery packs and sent recall letters on August 10, 2004. All Auria Battery Packs are to be returned per instructions in the recall letters. Firm rerecalled powerpaks that had been repaired since FDA review has found that repairs are not sufficent to address all potential adverse events concieveable. The latest recall letter was sent May 11-12, 2005

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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